Pan Medical , Ltd. FDA Record
- Latest inspection VAI · Apr 7, 2016
- No warning letters matched by name
Pan Medical , Ltd. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pan Medical , Ltd." is on file.
- Latest inspection
- Apr 7, 2016 · VAI
- Latest 510(k)
- Nov 1, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 3 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 7, 2016 | Gloucester, United Kingdom | Devices | Voluntary Action Indicated (VAI) | 3005146147 |
| May 10, 2012 | Gloucester, United Kingdom | Devices | Voluntary Action Indicated (VAI) | 3005146147 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005146147 | Gloucester, United Kingdom | 2 | Apr 7, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | Nov 1, 2016 |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini)… | Mar 6, 2015 |
| K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15… | Apr 16, 2014 |
Pan Medical , Ltd. and the FDA: common questions
Has Pan Medical , Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Pan Medical , Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Pan Medical , Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Pan Medical , Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pan Medical , Ltd.?
The most recent FDA inspection on file ended Apr 7, 2016 at Gloucester, United Kingdom and was classified VAI. FDA has 2 inspections of Pan Medical , Ltd. on file.
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